欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0251/001
药品名称
Silardex
活性成分
levocetirizine dihydrochloride 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Glenmark Pharmaceuticals s.r.o.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Romania (RO)
Poland (PL)
Bulgaria (BG)
Alercit
许可日期
2010/02/25
最近更新日期
2023/08/28
药物ATC编码
R06AE09 levocetirizine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
cc_pl_levo_v007_clean
Date of last change:2024/09/06
Final SPC
|
common_combined_spcclean
Date of last change:2024/09/06
Final Labelling
|
common_outer_1
Date of last change:2024/09/06
Final Labelling
|
common_pl_1
Date of last change:2024/09/06
Final Labelling
|
common_spc_1
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase